| Device Classification Name |
Clamp, Umbilical
|
| 510(k) Number |
K871075 |
| Device Name |
SCMT UMBILICAL CLAMP |
| Applicant |
| Salt Creek Medical Technologies |
| 5500 Arapaho Pass |
|
Pinckney,
MI
48169
|
|
| Applicant Contact |
HOWARD MEADE |
| Correspondent |
| Salt Creek Medical Technologies |
| 5500 Arapaho Pass |
|
Pinckney,
MI
48169
|
|
| Correspondent Contact |
HOWARD MEADE |
| Regulation Number | 884.4530 |
| Classification Product Code |
|
| Date Received | 03/18/1987 |
| Decision Date | 03/23/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Obstetrics/Gynecology
|
| 510k Review Panel |
Obstetrics/Gynecology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|